510(k) · Cleared
Recalled · 2012Sickle Cell Reagent Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Michclone Associates, Inc. · GHM Test, Sickle Cell
Cleared on Apr 11, 1986 after a 38-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled 3 times.
- Decided
- Apr 11, 1986
- Review
- 38 days
- Class
- Class II
- Product code
- GHM
- Recalls
- 3
- Predicates
- 0
FDA has not posted a summary or statement for it, so its predicates are not known.
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GHM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 23, 2012 | Not classified | Z-1503-2012 | Nonconforming Material/Component | Two complaints concerning the powder vial included in the 100 test kit has been observed producing pressure while sealed. When the powders are opened, the pressure from within the vial releases a small amount of powder into the air. This… |
| Feb 23, 2012 | Not classified | Z-1501-2012 | Nonconforming Material/Component | Michclone Associate's has received two complaints concerning the powder vial included in the 100 test kit observed producing pressure while sealed. When the powders are opened, the pressure from within the vial releases a small amount of… |
| Feb 23, 2012 | Not classified | Z-1502-2012 | Nonconforming Material/Component | Two complaints received concerning the powder vial included in the 100 test kit observed producing pressure while sealed. When the powders are opened, the pressure from within the vial releases a small amount of powder into the air. This… |
No ancestor or descendant has a Class I recall.
How does its category compare?
All GHM devicesGHM Test, Sickle Cell: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GHM
FDA has decided no GHM device since 2007.
Median 510(k) review, days · GHM
Too few GHM 510(k)s in any year since 2007 to give a median.
Recalls per year · GHM
3in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GHM
No MAUDE report names GHM since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 3 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K860812 · printed Nov 6, 2026
Cite this page
510(k) Report. “K860812: Sickle Cell Reagent Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K860812
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026